DIAPER RASH- zinc oxide cream

Diaper Rash by

Drug Labeling and Warnings

Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

• helps treat and prevent diaper rash
• protects chafed skin due to diaper rash and helps protect skin from wetness
• helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips
  

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product

avoid contact with the eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
• apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  

Other information

• store at room temperature
• Lot No and Exp Date: see box or see crimp of tube
  

Inactive ingredients

Talc, Vacillin, Bees wax, Demethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

Package label

Diaper Rash Cream

INGREDIENTS AND APPEARANCE

DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
MINERAL OIL (UNII: T5L8T28FGP)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0502-2	1 in 1 BOX	08/25/2011
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67510-0502-4	1 in 1 BOX	08/25/2011
2		114 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/25/2011

Labeler - Kareway Product, Inc. (121840057)